OCTAGAM 100 mg /Ml Solution

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. Octagam 10% Solution for Infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Octagam 10% and what is it used for
   1. What is Octagam 10%?
   2. What is Octagam 10% used for?
4. Important information before using Octagam 10%
   1. When not to use Octagam 10%
   2. Warnings and precautions
   3. Children and adolescents
   4. Octagam 10% and other medicines
   5. Effect on laboratory tests
   6. Thus, during administration of Octagam 10% or other products containing maltose, blood glucose should be measured using a system that uses a glucose-specific method. Systems based on glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose oxidoreductase should not be used.Read the information about the blood glucose measurement system, including test strips, to determine if the system is suitable for testing during concomitant use of parenterally administered maltose-containing products. In case of doubts, consult the treating doctor to determine if the glucose measurement system is suitable for testing during concomitant use of parenterally administered maltose-containing products.
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Octagam 10% contains sodium
5. How to use Octagam 10%
   1. Use in children and adolescents
   2. Overdose of Octagam 10%
   3. Missed dose of Octagam 10%
6. Possible side effects
   1. Reporting side effects
7. How to store Octagam 10%
8. Contents of the pack and other information
   1. What does Octagam 10% contain?
   2. What does Octagam 10% look like and what does the pack contain?
   3. Marketing authorization holder and manufacturer
   4. Manufacturer
   5. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   6. Date of revision of the leaflet: 15.07.2024
   7. The following information is intended for healthcare professionals only:

Patient Information Leaflet: User Information

Octagam 10% Solution for Infusion

Human Normal Immunoglobulin (IVIg)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
See section 4.

Table of Contents of the Leaflet

• 1. What is Octagam 10% and what is it used for
• 2. Important information before using Octagam 10%
• 3. How to use Octagam 10%
• 4. Possible side effects
• 5. How to store Octagam 10%
• 6. Contents of the pack and other information

1. What is Octagam 10% and what is it used for

What is Octagam 10%?

Octagam 10% is a solution of normal human immunoglobulin (IgG) (i.e., a solution of human antibodies) for intravenous administration (i.e., infusion into a vein). Immunoglobulins are normal components of the human body and support its immunity. Octagam 10% contains all IgG antibodies that occur in the normal human population. Appropriate doses of this medicinal product can restore abnormally low levels of immunoglobulin to normal.
Octagam 10% covers a broad spectrum of antibodies against various infectious agents.

What is Octagam 10% used for?

Octagam 10% is used for replacement therapy in children, adolescents (0-18 years) and adults in various patient groups:

• Patients with congenital antibody deficiency (primary immunodeficiency, such as congenital agammaglobulinemia and hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiency)
• Patients with acquired antibody deficiency (secondary immunodeficiency) caused by certain diseases and/or treatments and who have severe or recurrent infections

Octagam 10% can be used to treat susceptible adults, children, and adolescents (0-18 years) who have been exposed to measles or are at risk of measles exposure and for whom active measles vaccination is contraindicated or not recommended.
Octagam 10% may also be used to treat the following autoimmune diseases (immunomodulation):

• in patients with immune thrombocytopenia (ITP) - a disorder in which platelets are destroyed and their number decreases - in whom there is a high risk of bleeding or a need to correct platelet count before surgery;
• in patients with Kawasaki disease - a disease that leads to inflammation of various organs;
• in patients with Guillain-Barré syndrome - a disease that leads to inflammation of certain parts of the nervous system;
• in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - a disease that leads to chronic inflammation in the peripheral nervous system, causing numbness or weakness in the hands and feet;
• in patients with multifocal motor neuropathy (MMN) - a condition characterized by slowly progressive, asymmetric weakness of the limbs without sensory loss;
• in adult patients with active dermatomyositis (DM), which is a disease that causes inflammation of the muscles and skin lesions. Typical symptoms include progressive, symmetrical muscle weakness and typical skin lesions, such as a rash on various parts of the body (e.g., eyelids, cheeks, nose, back, elbows, knees) and scaly, dry skin. Octagam 10% can be used in patients treated with immunosuppressive drugs, such as corticosteroids, or if these drugs are contraindicated or not well tolerated.

2. Important information before using Octagam 10%

When not to use Octagam 10%

• if the patient has been found to be hypersensitive to human immunoglobulin or any of the other components of Octagam 10% (listed in section 6),
• if the patient has immunoglobulin A (IgA) deficiency and if the patient has antibodies against IgA immunoglobulins.

Warnings and precautions

Before starting treatment with Octagam 10%, discuss it with a doctor or pharmacist.
It is strongly recommended that in each case of administering Octagam 10% to a patient, the name and batch number of the medicine be recorded to maintain a connection between the patient and the batch of the administered medicine.
Certain side effects may occur more frequently:

• in case of high infusion rates,
• in patients receiving Octagam 10% for the first time or, in rare cases, with a large time interval since the previous infusion.
• if the patient has an untreated infection or chronic inflammatory condition.

In case of side effects, the infusion rate should be reduced or the infusion stopped. The required action in case of an adverse event will depend on the nature and severity of the side effect.
Circumstances and conditions that increase the risk of side effects

• In very rare cases, after administration of Octagam 10%, thromboembolic events such as myocardial infarction, stroke, and deep vein thrombosis, for example, in the leg or pulmonary vessels, may occur. These events occur more frequently, although still very rarely, in patients with risk factors such as obesity, advanced age, high blood pressure, diabetes, dermatomyositis, history of such events, prolonged immobilization, and taking certain hormones (e.g., oral contraceptives). In such a situation, balanced fluid intake should be ensured, and Octagam 10% should be administered at the lowest possible rate.

If the patient has had kidney problems in the past or has certain risk factors, such as diabetes, overweight, or age over 65, Octagam 10% will be administered at the lowest possible rate, as acute renal failure has been reported, although very rarely, in patients with such risk factors. If any of the above circumstances apply to the patient, even if it occurred in the past, they should inform their doctor.

• Patient with blood group A, B, or AB, as well as patients with certain inflammatory conditions, are at a higher risk of red blood cell destruction by the administered immunoglobulins (a phenomenon known as hemolysis).

In what cases may it be necessary to reduce the rate or stop the infusion?

• Rarely, within a few hours to 2 days after receiving Octagam 10%, severe headaches and neck stiffness may occur.
• Allergic reactions occur rarely; however, this medicine may cause anaphylactic shock, even in patients who have tolerated it well in the past. A sudden drop in blood pressure or shock may be a consequence of an anaphylactic reaction.
• In very rare cases, after administration of immunoglobulins, including Octagam 10%, acute post-transfusion pulmonary edema (TRALI) may occur, leading to non-cardiogenic pulmonary edema. Symptoms usually occur within 1 to 6 hours after administration of the medicine.

If the patient experiences any of the above reactions during or after the infusion of Octagam 10%, they should immediately inform their doctor or healthcare professional. The doctor or healthcare professional will decide whether to reduce the infusion rate or stop it completely and whether further action is necessary.

• Sometimes, immunoglobulin solutions, such as Octagam 10%, may cause a decrease in white blood cell count. This condition usually resolves on its own within 1-2 weeks.

Viral safety
In the case of medicines derived from human blood or plasma, measures should be taken to prevent the transmission of infectious diseases. These measures include:

• careful selection of blood and plasma donors to exclude carriers of infectious diseases,
• testing of individual donations and plasma pools for the presence of viruses/infections,
• virus inactivation or removal procedures used by manufacturers in the processing of blood or plasma. Despite these measures, when administering medicines manufactured from human blood or plasma, the risk of transmitting infectious agents cannot be completely excluded. This also applies to unknown or emerging viruses or other pathogens. Maintaining safety measures prevents the transmission of enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B and C viruses.

These safety measures may have limited applicability in the case of non-enveloped viruses, such as hepatitis A virus (HAV) and parvovirus B19.
Immunoglobulins are not associated with hepatitis A or parvovirus B19 infections, probably due to the protection of antibodies against these infections present in this product.

Children and adolescents

Regarding children and adolescents, there are no special or additional warnings or precautions.

Octagam 10% and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that are available without a prescription or have been vaccinated in the last three months.
The infusion line can be flushed before and after administration of Octagam 10% with 0.9% sodium chloride solution or 5% dextrose solution.
Concomitant administration of loop diuretics should be avoided.
Octagam 10% may reduce the effectiveness of live attenuated virus vaccines, such as measles, rubella, mumps, and chickenpox vaccines.
Vaccination with live attenuated virus vaccines should be performed with an interval of three months from the administration of immunoglobulin. In the case of measles vaccine, this effectiveness may be reduced for up to 1 year.

Effect on laboratory tests

Patient undergoing blood tests after receiving Octagam 10% should inform the person taking the blood or their doctor that they have received a human normal immunoglobulin solution, as it may affect the test results.
Blood glucose test
Certain types of systems used to measure blood glucose levels (so-called glucometers) may incorrectly recognize maltose contained in Octagam 10% as glucose. This can lead to falsely elevated glucose readings during infusion and for approximately 15 hours after the end of the infusion, resulting in inappropriate insulin administration leading to life-threatening hypoglycemia (i.e., low blood sugar).
Also, in cases of true hypoglycemia, treatment may not be initiated due to falsely changed elevated glucose readings.

Thus, during administration of Octagam 10% or other products containing maltose, blood glucose should be measured using a system that uses a glucose-specific method. Systems based on glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) or glucose oxidoreductase should not be used.
Read the information about the blood glucose measurement system, including test strips, to determine if the system is suitable for testing during concomitant use of parenterally administered maltose-containing products. In case of doubts, consult the treating doctor to determine if the glucose measurement system is suitable for testing during concomitant use of parenterally administered maltose-containing products.

Octagam 10% with food, drinks, and alcohol

No interactions have been observed. When using Octagam 10%, ensure adequate hydration before infusion.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The safety of using this medicine in pregnant women has not been established in controlled clinical trials and therefore should be administered to pregnant women and breastfeeding mothers with caution. It has been shown that IVIg products cross the placenta, which increases during the third trimester. Clinical experience with immunoglobulins suggests that they do not have a harmful effect on the course of pregnancy, fetal development, or the newborn.
Immunoglobulins are excreted into human milk. No adverse effect on breastfed infants/children is expected.
Clinical experience with immunoglobulins suggests that they are not expected to have a harmful effect on fertility.

Driving and using machines

Octagam 10% has no or negligible influence on the ability to drive and use machines. However, patients who experience side effects during treatment should not drive or operate machines until these side effects have resolved.

Octagam 10% contains sodium

100 ml of this medicine contains 69 mg of sodium (the main component of common salt), which is equivalent to 3.45% of the WHO-recommended maximum daily sodium intake for adults, which is 2 g.
This should be taken into account in patients controlling their sodium intake.

3. How to use Octagam 10%

The need to use and the dose of Octagam 10% are determined by a doctor. Octagam 10% is administered as an intravenous infusion by medical personnel. The dose and method of administration depend on the indication and require individual determination for each patient.

• In case of doubts about the use of the medicine, consult a doctor or pharmacist.

Use in children and adolescents

Administration (intravenously) of Octagam 10% to children and adolescents (0-18 years) does not differ from administration to adults.

Overdose of Octagam 10%

Overdose is very unlikely, as Octagam 10% is usually administered under medical supervision. If, despite this, the patient receives a higher dose of Octagam 10% than recommended, their blood may become too thick (overly viscous), which may increase the risk of blood clots. This may happen especially if the patient is at risk, for example, is elderly or has heart or kidney disease. Ensure adequate hydration. Inform the doctor about any health problems.

Missed dose of Octagam 10%

Discuss with the doctor and determine the next steps.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of any of the following side effects, contact a doctor immediately (these side effects are very rare and may occur less than 1 in 10,000 infusions).
In some cases, the doctor may need to stop the administration of the medicine and reduce the dose or discontinue treatment:

• Facial, tongue, and tracheal edemathat can cause significant breathing difficulties;
• Anaphylactic reactionwith shortness of breath, rash, wheezing, and low blood pressure;
• Strokethat can cause weakness or loss of sensation on one side of the body;
• Myocardial infarctioncausing chest pain;
• Blood clotscausing pain and swelling of the limbs;
• Pulmonary embolismcausing chest pain and shortness of breath;
• Anemiacausing shortness of breath or pallor;
• Severe kidney problemsleading to inability to urinate;
• Lung diseaseknown as acute post-transfusion pulmonary edema (TRALI) causing breathing difficulties, cyanosis, fever, and low blood pressure;
• Severe headachein combination with any of the following symptoms: neck stiffness, drowsiness, fever, sensitivity to light, nausea, vomiting (these may be symptoms of meningitis). In case of any of the above side effects, contact a doctor immediately.

In addition, the following side effects have been reported during the use of this medicine:
Common side effects(may occur in up to 1 in 10 infusions):

• Hypersensitivity (allergic reaction);
• Headache;
• Nausea;
• Changes in blood pressure;
• Fever.

Uncommon side effects(may occur in up to 1 in 100 infusions):

• Deficiency of various blood cells;
• Changes in heart rhythm;
• Vomiting;
• Stroke;
• Dizziness;
• Feeling of tingling, skin prickling;
• Tremors;
• Blurred vision;
• Blood clots in blood vessels;
• Deep vein thrombosis;
• Pulmonary embolism;
• Back pain;
• Chest pain;
• Joint or muscle pain;
• Involuntary muscle contractions;
• Pain in legs or arms;
• Breathing difficulties;
• Chills;
• Feeling of fatigue, general malaise, or weakness;
• Fluid in limb tissues;
• Reactions at the injection site;
• Abnormal blood test results (related to liver function or red blood cells).

Other side effects that did not occur in clinical trials but have also been reported are:

• Fluid overload;
• Low sodium levels in the blood;
• Feeling of excitement, anxiety, confusion, or nervousness;
• Migraine;
• Speech disorders;
• Loss of consciousness;
• Decreased sensation or feeling of touch;
• Sensitivity to light;
• Impaired vision;
• Angina pectoris;
• Palpitations;
• Transient blue discoloration of the lips or other skin areas;
• Respiratory arrest or shock;
• Phlebitis;
• Pallor;
• Cough;
• Pulmonary edema (fluid accumulation in the lungs);
• Bronchospasm (difficulty breathing or wheezing);
• Respiratory failure;
• Hypoxia;
• Diarrhea, abdominal pain;
• Urticaria, skin itching;
• Redness of the skin;
• Rash;
• Desquamation;
• Dermatitis;
• Hair loss;
• Muscle weakness or stiffness;
• Severe and painful muscle spasms;
• Neck pain;
• Kidney pain;
• Edema;
• Hot flashes, increased sweating;
• Discomfort in the chest;
• Flu-like symptoms;
• Feeling of cold or heat;
• Drowsiness;
• Burning sensation;
• False blood glucose readings.

Reporting side effects

If side effects occur, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C

• 02 - 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Octagam 10%

Keep the medicine out of the sight and reach of children.
Do not use Octagam 10% after the expiry date stated on the label and carton.
Store in a refrigerator (2°C – 8°C). Keep the container in the outer packaging to protect from light. Do not freeze.
The medicine can be taken out of the refrigerator once for a period of up to 9 months (not exceeding the expiry date) and can be stored at a temperature ≤ 25°C. At the end of this period, the medicine should not be put back in the refrigerator but should be discarded. The date of removal from the refrigerator should be recorded on the outer packaging.
Use the medicine immediately after first opening.
Do not use Octagam 10% if the solution is cloudy, sediment is present, or it is strongly colored.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What does Octagam 10% contain?

The active substance of the medicine is human normal immunoglobulin (human antibodies), a 10% solution (containing at least 95% immunoglobulin G).
The other ingredients are maltose and water for injections.

What does Octagam 10% look like and what does the pack contain?

Octagam 10% is a solution for infusion and is available in a vial (2 g/20 ml) or bottles (5 g/50 ml, 6 g/60 ml, 10 g/100 ml, 20 g/200 ml, 30 g/300 ml).
Pack sizes:
2 g in 20 ml
5 g in 50 ml
6 g in 60 ml
10 g in 100 ml
20 g in 200 ml
3 x 10 g in 3 x 100 ml
3 x 20 g in 3 x 200 ml
30 g in 300 ml
Not all pack sizes may be marketed.
The solution is clear or slightly opalescent, colorless or slightly yellow.

Marketing authorization holder and manufacturer

Octapharma (IP) SPRL
Allée de la Recherche 65
1070 Anderlecht
Belgium

Manufacturer

Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235, A-1100 Vienna, Austria
Octapharma AB
Lars Forssells gata 23
SE-112 75 Stockholm, Sweden

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Czech Republic, Denmark, Finland, France,
Latvia, Norway, Portugal, Slovenia, Sweden,
Hungary:
Octagam 100 mg/ml
Belgium, Bulgaria, Cyprus, Estonia, Netherlands,
Iceland, Lithuania, Luxembourg, Malta, Germany,
Poland, Romania, Slovakia, and the United Kingdom (Northern Ireland)
Octagam 10%
Italy:
Gamten 100 mg/ml
Spain:
Octagamocta 100 mg/ml

Date of revision of the leaflet: 15.07.2024

The following information is intended for healthcare professionals only:

• Before use, the product should be warmed to room temperature or body temperature.
• The solution should be clear to slightly opalescent and colorless to pale yellow.
• Do not use a cloudy or sediment-containing solution.
• Any unused product or waste material should be disposed of in accordance with local regulations.
• This medicinal product should not be mixed with other medicinal products.
• To administer the remaining medicine at the end of the infusion, the infusion line can be flushed with 0.9% sodium chloride solution or 5% dextrose solution.